# K034057: Lacrytest

- Pathway: 510(k) (Traditional)
- Applicant: Adiatec SA
- Decided: Mar 9, 2004 after 70 days
- Product code: DGC (Ige, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5510
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K964152 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964152: Unicap Total Ige Assay/Pharmacia Total Ige Controls LMH, Pharmacia, Inc. (1997) Summary page 1.

## Indications for use
Lacrytest is a rapid immunoassay for the detection of total IgE in tears. Semi-quantitative detection of total IgE in tears (< 2.5 klU/Iiter, 2.5 - 10 klU,qiter, 10 - 40 klU/liter, and > 40 klU/liter) indicates local IgE production associated with allergic conjunctivitis. This test is used in the physician office and professional clinical laboratories.

Source page: https://510kreport.com/device/K034057
Methodology: https://510kreport.com/methodology